Risperidone vs Cariprazine in Acute Mania

Risperidone vs Cariprazine in Acute Mania a Head to Head Comparison of Efficacy vs Tolerability

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07665073

Acronym

RCAM

Enrollment

Registered

2026-06-24

Start date

2027-06-01

Completion date

2028-06-01

Last updated

2026-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bipolar 1 Disorder

Brief summary

Randomized, double-blind, parallel-group study comparing efficacy and safety of Risperidone versus Cariprazine in adults with acute manic episodes. Participants will receive oral study drug for 6 weeks. Primary outcome is change in YMRS total score from baseline to week 6.

Detailed description

This is a randomized, double-blind, active-controlled, parallel assignment clinical trial conducted at Pakistan Institute of Medical Sciences, Islamabad. Adults aged 18-65 with ICD 11 diagnosis of Bipolar I Disorder, current episode manic, will be randomized 1:1 to receive Risperidone or Cariprazine for 6 weeks. The study aims to compare reduction in mania symptom severity and tolerability between the two antipsychotics. Assessments include YMRS, UKU and safety parameters at baseline, week 3, and week 6.'

Interventions

DRUGRisperidone

Oral Risperidone tablets, 2-6 mg/day administered once daily for 6 weeks. Dose titrated based on clinical response and tolerability. Approved antipsychotic for acute mania.'

DRUGCariprazine

Oral Cariprazine capsules, 1.5-6 mg/day administered once daily for 6 weeks. Dose titrated based on clinical response and tolerability. Approved antipsychotic for acute mania

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Caregiver)

Intervention model description

Randomized parallel assignment, double-blind, active-controlled trial comparing Risperidone vs Cariprazine in adults with acute manic episodes over 6 weeks.'

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

Inclusion criteria

patients with bipolar mania Age 18-60 YMRS\>20 -

Exclusion criteria

Patients with substance use Patients already taking antipsychotics Secondary mood disorder \-

Design outcomes

Primary

Measure	Time frame	Description
Change in YMRS total score from baseline to week 6	Baseline,week 6	The Young Mania Rating Scale YMRS is an 11-item clinician-rated scale measuring mania severity. Total score ranges 0-60, with higher scores indicating greater mania severity. Primary endpoint is change from baseline to week 6.

Contacts

CONTACTMaera Hussain

maerahussain802@gmail.com+92-3160886631

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 25, 2026